haemodialysis_quality_standards - Rotary International District 3310

MOH / P / PAK / 235.12 (GU)

Haemodialysis Quality 

And Standards 

Medical Development Division 

Ministry of Health Malaysia

This document was developed by the Medical Services Unit, Medical Development Division, 

Ministry of Health and the Drafting Committee for Haemodialysis Quality and Standards. 

Published in May 2012 

A catalogue record of this document is available from the library and Resource Unit of the Institute 

of Medical Research, Ministry of Health; 

MOH/P/235.12(GU) 

And also available from the National Library of Malaysia 

ISBN 978-967-0399-14-0 

All rights reserved. No part of this publication may be reproduced or distributed in any form or by 

any means or stored in a database or retrieval system without prior written permission from the 

Director of the Medical Development Division, Ministry of Health Malaysia.

CONTENTS 

Page 

List of Appendices 5 

Foreword 6 

List of Contributors 8 

1 Introduction 12 

2 Physical Facilities 13 

2.1 Introduction 

2.2 Dialysis Room/Area 

2.3 Treatment/Consultation Room 

2.4 Resuscitation Facilities 

2.5 Water Treatment Room 

2.6 Reprocessing Room 

2.7 

3 Equipment 15 

3.1 Haemodialysis (HD) Machines 

3.2 

3.3 Water Treatment System 

3.4 Dialyser Reprocessor 

4 Dialysis Consumables 23 

4.1 Dialysis Concentrate 

4.2 Dialysers 

4.3 Bloodlines 

4.4 

4.5 Clinical Waste Management 

5 Water Quality 25 

6 Human Resource 28 

7 Monitoring of Dialysis Patient 30 

8 Infection Control Measures 31 

9 Outcome Measures and Quality Initiatives in Dialysis 36 

10 Appendices 37 

11 

12 

References 

Glossary 

53 

54 

4 

Haemodialysis Quality and Standards

LIST OF APPENDICES 

Appendix 1: 

Microbial requirements for haemodialysis and related 

therapies. 

Page 

37 

Appendix 2: 

Maximum allowable levels of toxic chemicals and dialysis 

 

38 

Appendix 3: Daily R.O Water Treatment System Log Book. 39 

Appendix 4: 

 

Physician and Registered Medical Practitioner. 

40 

Appendix 5: 200 hours training. 41 

Appendix 6: Role of Person-In-Charge (PIC) and Nephrologist. 42 

Appendix 7: Monitoring of intra-dialytic complications. 43 

Appendix 8: Vascular Access Monitoring. 44 

Appendix 9: Dialysis Treatment Record. 45 

Appendix 10: 

Minimum laboratory investigations for chronic 

haemodialysis patients. 

46 

Appendix 11: 

Method of measurement of delivered dose of 

haemodialysis. 

47 

Appendix 12: Infection Control Precautions for all patients. 48 

Appendix 13: Recommended training on infection control in dialysis. 51 

Haemodialysis Quality and Standards 5

Foreword 

By The 

Director General of Health Malaysia 

 

of Health in 1994, much progress, development and advances have taken place. The numbers 

 

of the year 2010, the Ministry of Health was no longer the largest provider of haemodialysis 

 

were treated at private centres, thirty percent at the Non- Governmental Organization centres 

 

 

patients with end stage renal disease may be seen as a healthsector success, the mushrooming 

of hospital based or free standing haemodialysis units all over the nation does pose a new set 

of challenges. There is a need to ensure that haemodialysis treatment is prescribed, initiated, 

maintained and terminated by trained and appropriate technical and clinical professionals so 

that the elements of safety and standard are adhered to. 

As such, this revised and updated version of the national standards and quality document in 

haemodialysis is timely and relevant. I hope that this document will be used as a guide by all the 

relevant stakeholders to ensure that the provision of haemodialysis service in all health sectors 

 

saving treatment. 

Dato’ Sri Dr Hasan Abdul Rahman 

6 


Foreword 

By The 

Deputy Director General of Health Malaysia 

(Medical) 

In Malaysia, the evolution of haemodialysis from the short-term therapy for acute renal failure 

involving a handful of patients in the sixties has quickly expanded to become the most important 

long-term therapy for patients with end stage renal failure. 

While the haemodialysis service were mainly provided by the public sector in the eighties 

and early nineties, this is not the case now. While the density of public haemodialysis 

centres remained static at 5 per million population (pmp) between 2005 to 2010, the private 

haemodialysis centres doubled from 5 pmp in 2005 to 10pmp in 2010 while the Non- 

Governmental Organizations (NGO) centres increased from 4 to 5 pmp over the same period. 

Under the Private Healthcare and Facilities Act 1998, haemodialysis services in the private 

and NGO sectors are subjected to licensing and monitoring so as to ensure that they are 

provided to meet the needs of the patients as well as delivered by taking into consideration 

basic requirements of safety and standards. While the contents of the Act deal with the principle 

and basic issues, the Ministry of Health, assisted by the members of the nephrology service has 

 

ensure that such treatments conform to the required standards. In the process of preparing this 

document, several public sessions were held with the participation of clinicians and technicians 

from both the public and private sector. 

As this is a national document, the standards and requirements spelt therein will apply equally 

to the public, private and NGO facilities.It is my sincere hope that this document will contribute 

to better care for patients receiving long-term haemodialysis treatment in this country. 

Datuk Dr Noor Hisham Bin Abdullah 


LIST OF CONTRIBUTORS 

Editors: 

Datuk Dr Ghazali Ahmad 

Senior Consultant Nephrologist & Head of Department 

Hospital Kuala Lumpur 

Wilayah Persekutuan 

Dr Rosnawati Yahya 

Consultant Nephrologist 



Dr Ravindran Visvanathan 

Senior Consultant Nephrologist 



Contributors: 

Ministry of Health 

Dr Anita Bhajan Manocha 


Hospital Bukit Mertajam 

Penang 

Mr Charles Lazaar 

 



Dr Goh Bak Leong 


Hospital Serdang 

Selangor 

Tuan Hj Husin Harun 

 



Dr Lawrence Hii 


Hospital Umum Sarawak 

Kuching, Sarawak 

Dr Liew Yew Fong 


Hospital Pulau Pinang 

Penang 

8 


Dr Loh Chek Loong 


Hospital Raja Permaisuri Bainun 

Ipoh,Perak 

Dr Norleen Zulkarnain Sim 


Hospital Tengku Ampuan Rahimah 

Klang, Selangor Darul Ehsan 

Dr Ong Loke Meng 


Hospital Pulau Pinang 

Penang 

Dr Shahnaz Shah 




Dr Tan Chwee Choon 




Mr Tam Chong Chiang 

 

Hospital Tengku Ampuan Afzan 

Kuantan, Pahang Darul Makmur 

Dr Wan Hasnul Halimi Wan Hassan 


Hospital Raja Perempuan Zainab II 

Kota Bharu, Kelantan Darul Naim 

Dr Wong Koh Wei 


Queen Elizabeth Hospital 

Kota Kinabalu, Sabah 

Dr Zawawi Nordin 


Hospital Sultanah Nur Zahirah 

Kuala Terengganu, Terengganu Darul Iman 


ACKNOWLEDGEMENT 

Acknowledgement for the contribution and participation in the preparation of this document; 

Ministry of Health 

Dato’ Dr Azmi Shapie 

Director 


Ministry of Health Malaysia 

Dr Ahmad Razid Salleh 

Director 

Medical Practice Division 


 

Deputy Director 

Medical Practice Division 


Dr Inderjeet Kaur Gill 

Senior Principal Assistant Director 



Ministry of Education 

Prof Emeritus Datin Dr Norella Kong CT 


UKM Medical Centre 

Kuala Lumpur 

AP Dr Halim Ghafor 


UKM Medical Centre 

Kuala Lumpur 

Dr Lim Soo Kun 


University Malaya Medical Centre 

Kuala Lumpur 

Malaysian Society of Nephrology 

Dr Wong Hin Seng 

President 


Dr Wan Jazilah Wan Ismail 

Vice President 


10 


National Kidney Foundation 

Dato’ Dr Zaki Morad Mohd Zaher 

Chairman, Board of Directors 


Malaysia 

Dr Thiruventhiran Thilagannthan 

Vice Chairman, Board of Directors 


Malaysia 

Dr Lee Wan Tin 


Ex-Board of Directors 


Malaysia 

Private Health Sector 

Dr Prasad Menon 


Sime Darby Medical Centre 

Selangor Darul Ehsan 

Dr Philip Jeremiah 


Ampang Putri Hospital 


Dr Tan Hee Wu 


Assunta Hospital 


Dr Fan Kin Sing 


Gleneagles Medical Centre 

Kuala Lumpur 

Dr Yudisthra Ganeshadeva 


Johore Specialist Hospital 

Johore Bharu, Johore Darul Takzim 

Industry 

Mr Jeson Pragash 

Fresenius Medical Care Sdn Bhd 


CHAPTER 1: INTRODUCTION 


This document is subdivided into several sections to cover important aspects and 

components of chronic haemodialysis treatment 

1.2 Objectives 

The purpose of this guideline is to ensure that haemodialysis is performed safely and 

is compatible with professionally accepted current practice and local or internationally 

recognized standards. 

12 


CHAPTER 2: PHYSICAL FACILITIES 


There shall be adequate space and facilities for all haemodialysis activities to 

be performed in the haemodialysis centres and for the required volume of work, 

including: 

 

 

 

 

 

 

 

 

 

 

 

A storeroom with adequate space for supplies, consumables and equipment 

A suitable and secure area for clinical waste (Clinical Waste Area). 

Dialysis Room/Area 

Treatment/ Consultation Room 

Resuscitation Facilities 

Water Treatment Room 

Reprocessing Room 

Adequate conveniently located toilet and washbasins for the staff and patients 

Adequate ventilation by windows, ducts or mechanical means 

Janitor Room 

Waiting Area 

2.2 Dialysis Room/Area 

2.2.1 There shall be adequate space for dialysis machine and bed/couch/dialysis 

chair and such space shall not be less than 4.5 m 2 for each patient. 

2.2.2 HBsAg seropositive patients shall be dialysed in a separate room with 

dedicated machines, equipment, instruments, single use items and 

medications. 

2.2.3 Anti HCV seropositive patients shall be dialyzed in a separate room or a 

 

2.2.4 HIV seropositive patients shall be dialyzed in a separate room with dedicated 

machines, equipment, instruments, single use items and medications. 

2.3 Treatment/Consultation Room 

2.3.1 There shall be facilities and equipment for the treatment and care of end 

stage renal failure patients commensurate with the clinical procedures 

conducted within haemodialysis facilities. 

2.3.2 A haemodialysis centre providing or intending to provide minor procedures 

to haemodialysis patients under its care shall have a treatment room, which 

shall be located separate from the dialysis room/area. 


2.4 Resuscitation facilities 

The resuscitation equipment shall include, but not limited to, cardiac monitoring 

 

laryngoscope, endotracheal tube, drugs commonly used in medical emergency and 

oxygen supply, which shall be easily accessible. 

2.5 Water Treatment Room 

2.5.1 There shall be a separate room for water treatment. It shall be separated 

from the dialysis room and all other rooms. 

2.5.2 Water treatment room shall be appropriately sized to house all the 

components of water treatment system, to facilitate staff and technicians 

movement for maintenance and daily log purposes. 

2.5.3 Treated water shall be delivered to individual haemodialysis machines 

through pipes made of acrylonitrile butadiene styrene (ABS), cross-linked 

polyethylene (PEX) or equivalent material. 

[Note: ABS is not compatible with bleach nor heat disinfection] 

2.6 Reprocessing Room 

2.6.1 Where dialysers are reused, a separate dialyser reprocessing room shall 

be available. 

2.6.2 This room shall only be used for dialyser reprocessing, storing of reprocessed 

dialysers and sterilant. 

2.6.3 

2.6.4 There shall be a separate room for reprocessing dialysers of patients with 

Hepatitis B. 

2.6.5 There shall be a separate room for reprocessing dialysers of patients with 

Hepatitis C. 

2.6.6 For Hepatitis B & C co-infected patients, please refer to section (3.4.3) 

2.7 

 

system, or 

If drained into a septic tank, formaldehyde shall not be used and the tank size shall 

 

14 


CHAPTER 3: EQUIPMENT 

3.1 Haemodialysis (HD) machines 

3.1.1 HD machine shall be capable of performing conventional (diffusive) HD 

and preferably convective therapy. 

3.1.2 The machines shall be approved by regulatory authorities in USA, Europe 

or Japan. The machines shall also meet the conditions and regulations 

set up by the Director General of Health, Malaysia. 

3.1.3 Power supply 

There shall be a mechanism to ensure uninterrupted power supply to 

return blood from the extra-corporeal circuit in the event of power failure. 

3.1.4 Back-up Machine 

For centres running on full capacity [one (1) machine to six (6) 

patients], there shall be one back-up machine and 

 

For full capacity centres with more than ten (10) machines, a 

minimum of one back-up machine is required for every ten (10) HD 

machines. 

3.1.5 High Flux HD 

 

the dialysate shall be used. 

3.1.6 HD Machine Disinfection 

 

The external surfaces of the HD machines shall be disinfected after 

each dialysis session. 

 

Disinfection of the internal hydraulic circuit of the HD machines shall 

be performed after the last dialysis session of the day. However, it 

is preferable to disinfect after each haemodialysis session. 


3.1.7 Planned Preventive Maintenance (PPM) 

 

All machines shall have a PPM and technical safety check according 

to manufacturer recommendations. 

 

All PPM shall be documented. 

3.2 

3.2.1 HDF machine shall have a fully automated integrated unit that can 

 

3.2.2 

 

 

 

 

 

least meet the ISO 23500:2011 Standards. 

3.3 Water treatment system 

3.3.1 Introduction 

(Appendix 1) 

Water treatment system is an important component in haemodialysis 

treatment. It has to be well maintained and monitored in order to prevent 

any complication that may arise from chemical and microbiological 

contamination. Chemical contaminants may give rise to haemolysis 

and encephalopathy whereas, bacterial contamination may give rise to 

 

which can eventually lead to amyloidosis, suboptimal response to 

Erythropoiesis Stimulating Agents (ESA), malnutrition and accelerated 

atherosclerosis. Therefore, all centres shall adhere to the standards for 

maximum allowable chemical, bacterial and endotoxin contamination 

based on minimum requirements of ISO 23500:2011 Standards. 

(Appendix 1 & 2) 

16 


3.3.2 Basic requirements in a water treatment system 

 

 

 

 

 

 

 

 

The room that houses the water treatment system shall be 

located in an area, which minimizes the noise and disruption to 

haemodialysis treatment. 

There shall be adequate ventilation to prevent over-heating. 

Floor traps shall be made available to drain excess water. 

Flow diagram of the water treatment system shall be displayed in 

the water treatment room. 

All water treatment components and equipment shall be clearly 

labelled. 

All columns in pre-treatment shall be opaque. 

Pressure gauge shall be installed before and after each component 

to monitor fouling of the components. 

Daily recording of the parameters of water treatment system shall 

be performed. 

(See Appendix 3) 

 

 

Daily testing for chlorine/chloramine and hardness shall be done 

every morning prior to starting haemodialysis treatment. 

All centres shall have a water treatment system that delivers water 

quality that meets the ISO 23500:2011 Standards. 

(Appendix 1 & 2) 

3.3.3 Components of Water Treatment System 

(a) Raw Water Tank 

 

 

 

 

 

Appropriate material shall be used for water storage. Examples: 

stainless steel-grade 316, high-density polyethylene (HDPE) 

Shall be covered 

 

Shall be inspected for defects and cleaned at 6 monthly intervals 

Shall have an appropriate capacity that is adequate to enable 

at least one shift of treatment to be completed if water supply is 

disrupted 


(b) Raw water pump 

 

Two stainless steel raw water pumps are recommended 

(c) Multimedia Sediment Filter 

 

Backwash is required 1-3 times per week 

(d) Carbon Columns 

 

 

Empty Bed Contact Time (EBCT) shall be ten (10) minutes in total 

 

to optimise the chlorine and chloramines removal. 

Backwash is required one to three (1-3) times per week and the 

process shall be done individually for each column by adjusting the 

timer one to two (1-2) hours apart. 

(e) Softener Column 

 

 

Consist of polymer resin, which will be regenerated by Sodium 

Chloride from brine tank or equivalent 

Shall be placed after Carbon Column 

(f) Guard Filter 

 

 

 

 

Removes particles between 1-5 microns in diameter 

Safe guard the Reverse Osmosis unit pump and membranes from 

clogging 

Casing shall be opaque 

Filter shall be replaced as necessary or when there is pressure 

difference of 15 psi before and after the Guard Filter. However, a 

 

18 


(g) Reverse Osmosis (RO) Module 

 

 

 

(Refer to Water Quality). 

Type of RO membrane: Spiral Wound Polyamide, TEC of 

Polysulfone or equivalent. 

The recovery rate of RO system shall be at least 50%. 

 

Standard water treatment system shall have the following 

parameters displayed: 

• 

• 

• 

• 

• 

• 

Conductivity of permeate 

 

 

Raw water pressure 

Guard-in & guard-out pressure 

RO (membrane) system-in & system-out pressure 

 

Water sample ports shall be available for sampling at the following 

points: 

• 

• 

• 

• 

• 

• 

• 

 

Post second carbon column 

Post softener column/Pre-RO module 

Immediate post RO module 

First point in the distribution loop 

Last point in the distribution loop 

Last point of the dialyzer-reprocessing loop. 

 

In the event of RO pump failure, the softened water shall be 

diverted into the 0.2 microns Bacterial Filter as temporary measure. 

However, this shall not exceed 24 hours. 


(h) Treated Water Storage Tank 

 

 

 

 

The treated water storage tank is used primarily for dialyser 

reprocessing or indirect feed for dialysis. 

Shall be made of stainless steel (Grade 316) or High Density 

Polyethylene (HDPE) with a conical or bowl shaped bottom and 

shall drain from the lowest point of the base to ensure complete 

emptying of the tank. 

 

Irradiator for destruction of bacteria. There shall be an air vent with 

 

Two booster pumps are recommended for channelling the RO 

 

(i) Water Distribution Loop 

 

 

 

 

Treated water from the water treatment system shall be distributed 

to the individual dialysis stations, dialyser reprocessing stations 

using distribution materials and designs which will minimize or 

avoid microbiological contamination. 

Material of the distribution loop varies from Acrylonitrile butadiene 

styrene (ABS), cross-linked polyethylene (PEX), stainless steel 

(high grade 316L) or equivalent. 

Materials suitable for heat disinfection include cross-linked 

polyethylene (PEX), Polyvinylidene Fluoride and stainless steel. 

If ozone disinfection is used, all the above materials are suitable 

except PEX. 

20 


(j) Disinfection of Distribution Loops 

 

 

 

A minimum ofsix (6) monthly 

recommendation) chemical disinfection of distribution loop 

including the connections to dialysis machine shall be done using 

peracetic acid 2-3% or chlorine dioxide especially when materials 

of distribution loop are not heat resistant. 

Weekly heat disinfection of the tank and distribution loop is 

recommended for a system which incorporates a heater and uses 

heat resistant piping. 

 

velocity of 1.5 feet per second (FPS) for direct feed system and 3.0 

FPS for indirect feed system. 

Additional disinfection may be needed in the following 

circumstances: 

(i) 

(ii) 

(iii) 

(iv) 

(v) 

Installation of new system 

Upgrading of existing system 

Out-break of pyrogenic reaction 

Breach of the closed loop system. 

When microbial testing of treated water reach action level 

(refer section 5.3.5). 

3.4 Reprocessing 

3.4.1 Dialyser Reprocessing Machine 

 

The reprocessing machine shall be approved by regulatory 

authorities in the USA or equivalent. 

 

The reprocessing machine shall be a fully automated integrated 

 

 

For reprocessing of dialyser, this shall include testing for total cell 

volume (TCV), membrane integrity and perform disinfection as per 

AAMI standard. 

 

 

 

 


3.4.2 Dialyser Reprocessing Procedure 

 

 

 

 

 

 

 

The reprocessing machine shall be calibrated every morning with 

TCV calibration cell. 

The dialyser shall be cleansed of residual blood and blood products 

and rinsed with RO water. 

The dialyser shall be tested for residual membrane performance 

[(Total Cell Volume (TCV)] and the presence of leaks. Dialyzers 

with TCV

CHAPTER 4: DIALYSIS CONSUMABLES 

4.1 Dialysis Concentrate 

4.1.1 Commercially prepared dialysate 

Commercially prepared or ready-made dialysate shall be accompanied 

 

 

4.1.2 On-site dialysate preparation 

 

Due to lack of technical support and expertise, on-site dialysate 

preparation is currently not recommended. 

 

However, centres that currently prepare on-site dialysate shall 

comply with the 1SO 23500:2011 Standards and establish a 

Standard Operating Procedure (SOP) on dialysate preparation 

and dispensing. 

4.1.3 The dialysate packaging shall have the following information clearly 

labelled: 

 

 

 

 

Address of manufacturer 

Contents 

Concentration of electrolytes 

Dialysate concentration ratio 

 

Date of manufacture and expiry 

4.2 Dialysers 

4.2.1 Dialysers used for haemodialysis treatment shall be approved by 

regulatory authorities in USA, Europe, Japan or local equivalent. 

4.2.2 Dialysers made from biocompatible membrane shall be used. 


4.3 Bloodlines 

4.3.1 Bloodlines used for haemodialysis treatment shall be approved by 

regulatory authority. 

4.3.2 Bloodlines shall not be re-used. 

4.4 

Arterio-venous needle used for haemodialysis treatment shall be approved by 

regulatory authority. 

4.5 Clinical Waste Management 

The disposal of clinical waste shall follow the current Ministry of Health guidelines. 

24 


CHAPTER 5: WATER QUALITY 

5.1 Dialysis water shall be produced by the process of Reverse Osmosis. 

5.2 The minimum standards indicated below is based on the ISO 23500: 2011 

5.3 Chemical Contaminants 

5.3.1 Permissible levels of chemical contaminants shall be observed and 

adhered to. (See Appendix 2) 

5.3.2 Method of Testing 

 

 

Chlorine and Chloramines and water hardness testing shall be 

performed onsite using commercially available test kits. 

Full analysis for chemical contaminants shall be performed by an 

accredited laboratory. 

5.3.3 Minimum Frequency of Testing 

 

 

Daily using commercially available test kits for chlorine and 

chloramines. 

Six (6)-monthly testing in an accredited laboratory for chemical 

analysis. 

5.3.4 Site of Testing 

 

 

 

Daily testing for Chlorine and Chloramines shall be done after 

each carbon column. 

Daily testing for hardness after softener column. 

Six (6)-monthly full laboratories testing for chemicals shall be 

done at raw water point, pre and post RO. 

5.3.5 Action if limits exceeded 

Evaluate water treatment system and rectify as necessary. 


5.3.6 Record 

 

All the results shall be properly documented and made available 

for inspection. 

5.4 Microbial Contaminant 

5.4.1 Method of Testing 

 

 

 

Total Viable counts (Colony Forming Units) using spread plate 

 

Agar (TGEA) or equivalent. 

Calibrated loop technique shall not be used. 

The presence of pyrogen/endotoxin shall be determined using 

Limulus Amoebocyte Lysate (LAL) method. 

5.4.2 Frequency of Testing 

 

Monthly for bacterial count and endotoxin test 

5.4.3 Sites of Sampling 

 

Minimum sites of sampling for testing 

i. Post RO membrane 

ii. 

iii. 

iv. 

First point of the distribution loop 

End point of distribution loop (Last machine port) 

Reprocessing bay (for indirect feed) 

5.4.4 Handling of water sample 

 

 

Assay within 30 minutes of collection 

If immediate assay is not possible, refrigerate immediately at 5 o C 

and assay within 24 hours of collection 

26 


5.4.5 Limits and Action Level 

Maximum Allowed 

 

 

CFU level < 100 CFU/ml 

Endotoxin level < 0.25 EU/ml 

Action Level 

 

 

CFU level > 50 CFU/ml 

Endotoxin Level> 0.125EU/ml 

(Ref: AAMI/ISO 23500: 2011) 

If Action Levels are observed, disinfection and retesting shall be done 

immediately to restore the quality into acceptable level. 

5.4.6 Laboratory 

All samples shall be sent to an accredited laboratory recognized by the 

Director General of Health. 

5.4.7 Record 

All the results shall be properly documented and made available for 

inspection. 


CHAPTER 6: HUMAN RESOURCE 

6.1 Provision of haemodialysis facilities and services 

Haemodialysis services shall be provided in compliance with existing laws and 

regulations. 

6.2 Human Resource 

6.2.1 Person-In-Charge (PIC) 

The person in charge (PIC) of a haemodialysis centre shall be: 

 

 

 

 

A Nephrologist or 

A Paediatric Nephrologist or 

A Physician who had completed not less than 200 hours of 

recognized training in haemodialysis treatment and maintains an 

 

A Registered Medical Practitioner other than those listed abovewho 

had completed not less than 200 hours of recognized training in 

haemodialysis treatment before 31 Dec 2011 and maintains an 

 

(Appendix 4) 

6.2.2 Registered Nurse/Medical Assistant 

A registered nurse/medical assistant shall have at leastsix (6) 

months training and experience in haemodialysis and care of 

such patients under the supervision of registered nephrologists 

prior to performing haemodialysis treatment independently. An 

adequate number of staff is required in the facilities to ensure care 

and treatments are performed safely and effectively. 

 

For every six (6) dialysis patients, there shall be at least one 

(1) registered nurse/medical assistant with at least six months 

training in haemodialysis treatment and care in each shift. 

 

 

as recognized by the Director General of Health. 

 

There shall be at least one (1) registered nurse/medical assistant 

with training in cardiopulmonary resuscitation techniques in each shift. 

28 


6.3 Prescribing haemodialysis treatments 

All haemodialysis treatment including self-care haemodialysis shall be provided 

under the order of: 

(a) 

A nephrologist or a paediatric nephrologist. 

(b) 

A physician with requisite training under the supervision of a nephrologist. 

6.4 Persons performing haemodialysis treatment 

6.4.1 Haemodialysis treatment and care shall be performed by: 

(a) 

A registered nurse or 

(b) 

A registered medical assistant 

With training and experience in haemodialysis treatment and care. 

6.4.2 A registered nurse/medical assistant shall have at least six months 

training and experience in haemodialysis and care of such patients, 

under the supervision of registered nephrologists prior to performing 

haemodialysis treatment independently. 

6.4.3 Nursing staff other than a registered nurse may assist in the 

haemodialysis treatment and care of patients but may only perform 

such treatment and care under direct supervision of a trained registered 

nurse/medical assistant. 


CHAPTER 7: MONITORING OF DIALYSIS PATIENT 

7.1 Monitoring of patients during dialysis 

The dialysis treatment shall be monitored closely, with particular attention to: 

Any intra-dialytic complications (Appendix 7) 

 

Vital signs during dialysis: Blood Pressure, pulse & temperature 

Vascular Access (Appendix 8) 

7.2 Records of dialysis treatments 

Each dialysis treatment shall be recorded (Appendix 9) 

7.3 Long-term monitoring of dialysis patients 

7.3.1 Blood Investigations 

Blood investigations shall be done regularly at three (3) monthly 

intervals or more often as necessary. (Appendix 10) 

7.3.2 Dialysis Adequacy 

Dialysis adequacy shall be monitored at least every three(3) 

monthly. 

 

 

This can be calculated using Kt/V or Urea Reduction Ratio 

(URR). (Appendix 11) 

The delivered Kt/V shall be more than 1.2 or 

The URR shall be more than 65%. 

30 


CHAPTER 8: INFECTION CONTROL MEASURES 

8.1 All haemodialysis centres shall have stringent measures to prevent the risk of crossinfection 

amongst haemodialysis patients. 

8.2 Management of Staff working in haemodialysis unit 

8.2.1 Annual screening for blood born viruses shall be performed. 

Staff who are HBsAg negative and: 

8.2.2 

 

If anti HBs antibody is 0, a full course vaccination shall be given. 

 

If anti HBs antibody

8.3.4 Vaccination Schedule 

 

A four (4) doses double-strength vaccination schedule is 

recommended at zero (0), one (1), two (2) and six (6) months. 

 

Serum anti-HBs Ab shall be checked one to two (1-2) months after 

completing the vaccination course. 

 

Those that do not develop anti-HBs Ab response (>10mIU/ml) 

after primary vaccination shall be re-immunized. 

 

Re-immunization consists of one to three (1-3) doses, after which 

if they remain negative are unlikely to respond to additional doses. 

8.3.5 Haemodialysis staff caring for HBsAg positive patients shall not care for 

Hepatitis B susceptible patients at the same shift. 

8.3.6 The licensee/person-in charge shall notify Ministry of Health of any 

Hepatitis B seroconversion. 

8.4 Hepatitis C: Prevention & Isolation Practice 

8.4.1 Patients shall be tested for anti HCV antibody: 

 

 

 

After returning from another haemodialysis facility. 

8.4.2 In anti HCV negative patients, serological test (ELISA) shall be repeated 

every three (3) months. 

8.4.3 

8.4.4 

not require repeated serological test. 

32 


8.4.5 In some situations such as recent transfusion of blood/blood products or 

temporary dialysis in another unit, it is recommended to do monthly ALT 

testingfor three months,as itwill facilitate earlier detection of new HCV 

infections. 

If ALT is elevated: 

 

In patients who are anti-HCV negative, repeat anti HCV testing is 

warranted, however 

 

If anti HCV remains negative, HCV NAT (Nucleic Acid Testing) 

shall be done. 

8.4.6 All anti HCV positive patients shall be isolated in a separate room or 

 

separate machines, equipment and instruments. 

8.4.7 The licensee/person-in charge shall notify the Ministry of Health of any 

Hepatitis C seroconversion 

8.5 Hepatitis B and C co-infection 

8.5.1 Wherever possible, combined Hepatitis B & Hepatitis C infected patients 

shall be isolated. 

8.5.2 If the isolation facility for combined Hepatitis B & C is not available, the 

patient shall be dialyzed in a Hepatitis B isolation facility during the last 

shift. 

8.5.3 Single use of dialyser is mandatory. 

8.6 

8.6.1 Patients shall be tested for anti HIV antibody: 

 

 

 

After returning from another haemodialysis facility 


8.6.2 In HIV negative patients, serologic test shall be performed every three 

(3) months. 

8.6.3 HIV positive patients shall be isolated in a separate room. They shall be 

dialyzed using separate machines, equipment, instruments and single 

use items. 

8.6.4 Single use of dialyser is mandatory. 

8.6.5 The licensee/person-in charge shall notify the Ministry of Health of any 

cases of HIV seroconversion. 

8.7 Recommendations on preventing transmission of 

infection among chronic haemodialysis patients 

8.7.1 Management of potentially infected patients 

Patients at risk of acquiring viral infection include: 

 

All new patients with an unknown viral status 

 

All patients with negative viral status returning from another 

haemodialysis facility 

 

All patients with history of recent transfusion of blood/ blood 

products 

These patients are strongly recommended to be dialysed with single 

use dialyser and either dialysed on: 

 

A machine that is dedicated for an unknown viral status or 

 

A machine for serology negative patient at the last shift. 

until the patient is out of the window period for the respective infection. 

34 


8.7.2 Infection Control Precautions for all patients 

Staff working in haemodialysis unit shall ensure implementation of, and 

adherence to strict infection control procedures designed to prevent 

cross-infection.(Appendix 12) 

8.7.3 Infection Control Training and Education 

Training and education is recommended for both staff members and 

patients (or their family and care givers). (Appendix 13) 


CHAPTER 9: OUTCOME MEASURES AND QUALITY INITIATIVES 

IN DIALYSIS 

9.1 Reporting to National Renal Registry 

 

9.2 Recommended Standards 

 

Dialysis Adequacy (Kt/V) 

> 95% of patients have prescribed Kt/V >1.3 

> 90% of patients have delivered Kt/V >1.2 

OR 

 

Urea Reduction Ratio (URR) 

> 90%have URR> 65% 

9.3 Anaemia 

Haemoglobin (Hb) 

> 70% achieved Hb > 10 g/dl 

 

Ferritin 

> 90% achieved serum ferritin > 100 ng/ml 

 

Transferrin Saturation (Tsats) 

> 80% achieved t sat > 20% 

9.4 Mandatory Incident Reporting to Ministry of Health 

 

 

All hepatitis and HIV seroconversion 

Intra-dialytic death in chronic stable dialysis patient 

36 


Appendix 1 

Microbial requirements for haemodialysis and related therapies 

Colony Forming 

Unit [CFU/ml] 

Endotoxin 

[EU/ml] 

Dialysis Water (Permeate)

Appendix 2 

 

electrolytes in dialysis water 

Contaminant 

Contaminants with documented toxicity in haemodialysis 

Maximum Concentration (mg/l) 

Aluminium 0.01 

Total Chlorine 0.1 

Copper 0.1 

Fluoride 0.2 

Lead 0.005 

Nitrate (as N) 2 

Sulphate 100 

Zinc 0.1 

 

Electrolytes 

Maximum Concentration 

(mg/dl) 

(mmol/l) 

Calcium 2 0.05 

Magnesium 4 0.15 

Potassium 8 0.2 

Sodium 70 3.0 

Maximum allowable levels of trace elements in dialysis water 

Contaminants 

Maximum Concentration (mg/l) 

Antimony 0.006 

Arsenic 0.005 

Barium 0.1 

Beryllium 0.0004 

Cadmium 0.001 

Chromium 0.014 

Mercury 0.0002 

Selenium 0.09 

Silver 0.005 

Thallium 0.002 

From ISO 23500: 2011 

38 


Appendix 3 

DAILY R.O WATER TREATMENT SYSTEM LOG BOOK 

Work Instruction Mon Tue Wed Thu Fri Sat Sun 

1. Water level in Raw Water Tank (Adequate? 

Please Tick) 

2. Timers of Pre Treatment Columns (Ensure 

corresponds to actual time) 

2.1: Multimedia column (tick) 

2.2: Carbon Column (tick) 

2.3: Softener Column (tick) 

3. Level of brine solution in Brine Tank 

(Adequate? Please Tick) 

4. Pressure Reading of Pre Treatment 

4.1: Pressure Pre Multi media Column 

4.2: Pressure Pre Carbon Column 1 

4.3: Pressure Pre Carbon Column 2 

4.4: Pressure Pre Softener Column 

4.5: Pressure of Guard Filter Inlet 

4.6: Pressure of Guard Filter Outlet 

4.7: Pressure of Pre RO Membrane 

4.8: Pressure of Post RO Membrane 

4.9: Permeate (Product) Pressure 

5. Permeate Flow Rate (LPM) 

6. Reject Flow Rate (LPM) 

7. Permeate Conductivity (micros/cm) 

8. Feed Total Chlorine (PPM) 

9. Feed Hardness (mg/L) 

Signature of Staff 

Please record maintenance work done: 

 

ii) 

Topping of vacuum salt 

iii) Sanitizing/ Cleaning of RO membrane 

iv) Sanitizing RO Water Distribution Loop 

Remarks: 


Appendix 4 

 

Nephrologist 

A nephrologist is a physician who has completed a recognized post-graduate training in 

nephrology in an accredited centre and registered with the National Specialist Register, 

Academy of Medicine Malaysia. 

Paediatric Nephrologist 

A paediatric nephrologist is a paediatrician who has completed a recognized post-graduate 

training in paediatric nephrology in an accredited centre and registered with the National 

Specialist Register, Academy of Medicine Malaysia. 

Physician 

A physician is a licensed medical practitioner, who has completed a recognized post-graduate 

training in Internal Medicine and registered with the National Specialist Register Academy of 

Medicine Malaysia. 

Registered Medical Practitioner 

A Registered Medical Practitioner is a licensed medical practitioner with or without recognized 

post-graduate training. 

40 


Appendix 5 

200 hours training for Physicians 

Objectives: 

 

 

 

maintenance haemodialysis treatment in a safe and competent manner. 

To improve the quality of care of haemodialysis patients. 

Training Module 

 

 

Lectures (15 hours) 

Practical experience (185 hours) in an accredited haemodialysis centres 

Eligibility 

 

Physicians who are registered with the National Specialist Register Malaysia 

How to apply 

 

Eligible candidates can apply through www.msn.org.my 

 

 

 


Appendix 6 

Role of Person-In-Charge (who is a non-nephrologist) 

Responsibilities of the person in charge shall include but not limited to: 

 

 

Day-to-day medical care of haemodialysis patients. 

Ensure that each patient has a nephrologist to assume all or part of the medical care of 

the patient. 

Role of Nephrologist 

 

 

 

 

 

management. 

c) Advise on policies and standards for haemodialysis treatment in conformity with the 

requirements of the regulations and/or any nationally accepted guidelines. 

d) Conduct review of patients at not less than three monthly intervals. Such review 

shall include but not limited to clinical examination, review of blood test results, and other 

test results. 

 

 

time in order to maintain the quality of care. 

42 


Appendix 7 

Monitoring of intra-dialytic complications 

During dialysis, patient shall be closely monitored for: 

 

 

 

 

 

 

 

 

Nausea, vomiting, and headache 

Hypotension or hypertension 

Pyrogenic reaction: chills, rigors, fever during dialysis 

Haemolysis 

Acute blood loss 

Air embolism 

Altered mental status 

Signs and symptoms of First Use Syndrome including chest pain, anxiety, shortness of 

breath, and back pain. 


Appendix 8 

Vascular Access Monitoring 

Continuous assessment for signs and symptoms of vascular access complications shall be 

performed during each haemodialysis: 

 

 

 

 

 

 

 

 

 

 

Venous Pressure 

Thrombosis 

Mechanical failure 

Infection 

Skin erosion 

Aneurysm or pseudo aneurysm 

 

Catheters: 

 

 

 

Exit site inspection 

Signs of catheter thrombosis 

Symptoms & signs of catheter related blood stream infection. 

44 


Appendix 9 

Date 

Type of dialysers 

No of Use 

Blood Flow Rate 

Dialysate Flow Rate 

Venous 

Pressure 

Heparin 

Blood 

Pressure 

Weight (kg) 

Target UF 

Intra-dialytic 

complications 

Medication(s) 

served 

Loading 

Dose 

Infusion 

Pre HD 

Intra 

Post HD 

Dry 

Pre HD 

Post HD 

IDWG * 

ESA** 

Iron 

Calcitriol 

DIALYSIS TREATMENT RECORD 

MONTH ____________ YEAR __________ 

*IDWG: Inter-Dialytic Weight Gain. ** ESA: Erythropoiesis Stimulating Agents 


Appendix 10 

Minimum laboratory investigations for chronic haemodialysis 

patients 

TESTS 

Full blood count 

Iron Study: 

Serum Iron 

Serum ferritin 

Total Iron Binding Capacity (TIBC) 

Iron saturation (Tsats) 

Blood Urea (pre & post dialysis) 

Renal Function Test 

Liver Function Test 

Alanine Transaminases 

Alkaline phosphatase 

Serum albumin 

Calcium & phosphate 

FREQUENCY 

Every 3 monthly 





Consider monthly transaminases for 3 months 

in patients who has been dialyzing elsewhere 

or patients who received blood transfusion. 


Fasting iPTH 

Every 3-6 monthly 

Fasting Serum Lipid 


Blood sugar 

Every 3 monthly (diabetics) 

Every 6 monthly (non-diabetics) 

HbA1C (if diabetics) 

Virology 

HBs Ag 

Anti HB s Ab titre 

Anti HCV 

Anti HIV 

Every 3-6 monthly 



Every 3 monthly (if anti HCV neg) 


46 


Appendix 11 

Method of measurement of delivered dose of haemodialysis 

The delivered dose of haemodialysis in adult and paediatric patients should be measured using 

formal urea kinetic modelling, employing the single-pool, variable volume model. Other methods 

include URR (urea reduction ratio), natural log Kt/V and the Daugirdas second-generation 

formula 

Formal urea kinetic modelling provides a quantitative method for developing a treatment for 

 

to compute Kt/V using formal UKM. 

Various websites offer free formula for calculation of Kt/V: 

 

 

 

www.hdcn.com/calc.html 

www.kt-v.net/ 

www.ureakinetic.org 

Kt/V natural logarithm formula 

Kt/V = -Ln(R - 0.008 × t)+(4 - 3.5 ×R) ×UF/W 

Ln 

R 

T 

 

W 

Natural logarithm 

 

 

 

 

Urea Reduction Ratio (URR) 

Formula for calculation of URR: 

URR = Predialysis Urea - Postdialysis Urea x 100% 

Predialysis Urea 


Appendix 12 

Infection Control precautions for all patients 

(Adapted from CDC guidelines) 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proper hand washing technique. 

 

at the dialysis station. Ensure a supply of clean non-sterile gloves and a glove discard 

container near each dialysis station. 

Wash hands after gloves are removed and between patient contacts, as well as after 

 

 

washing. 

If hands are not visibly soiled, use of a waterless antiseptic hand rub can be substituted 

for hand washing. 

 

machines, shall be disposed of, dedicated for use only on a single patient, or cleaned 

and disinfected before being returned to a common clean area or used for other patients. 

 

station shall not be returned to a common clean area or used on other patients. 

Prepare medications in a room or area separated from the patient treatment area and 

designated only for medications. 

Do not handle or store contaminated (used supplies, used equipment, blood samples, 

or biohazard containers) in areas where medications and clean (unused) equipment and 

supplies are handled. 

Deliver medications separately to each patient. Common carts shall not be used within 

the patient treatment area to prepare or distribute medications. 

If trays are used to distribute medications, clean them before using for a different patient. 

Intravenous medication vials labelled for single use, including erythropoietin, shall not be 

punctured more than once. Once a needle has entered a vial labelled for single use, the 

sterility of the product can no longer be guaranteed. 

Residual medication from two or more vials shall not be pooled into a single vial. 

48 


If a common supply cart is used to store clean supplies in the patient treatment area, 

 

to avoid contamination with blood. Such carts shall not be moved between stations to 

distribute supplies. 

Staff members shall wear gowns, face shields, eye wear, or masks to protect themselves 

and prevent soiling of clothing when performing procedures during which spurting or 

spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning 

of dialyzers, and centrifugation of blood). 

Such protective clothing or gear shall be changed if it becomes soiled with blood, body 

 

Staff members shall not eat, drink, or smoke in the dialysis treatment area or in the 

laboratory. 

Patients can be served meals or eat food brought from home at their dialysis station. The 

glasses, dishes, and other utensils shall be cleaned in the usual manner; no special care 

of these items is needed. 

Establish written protocols for cleaning and disinfecting surfaces and equipment in the 

dialysis unit, including careful mechanical cleaning before any disinfection process. If the 

manufacturer has provided instructions on sterilization or disinfection of the item, these 

instructions shall be followed. For each chemical sterilant and disinfectant, follow the 

 

After each patient treatment, clean environmental surfaces at the dialysis station, 

including the dialysis bed or chair, countertops, and external surfaces of the dialysis 

machine, including containers associated with the prime waste. Use any soap, detergent, 

or detergent germicide. 

Between uses of medical equipment (e.g., scissors, haemostats, clamps, stethoscopes, 

blood pressure cuffs), clean and apply a hospital disinfectant (i.e., low-level disinfection); 

if the item is visibly contaminated with blood, use a tuberculocidal disinfectant (i.e., 

intermediate-level disinfection). 

For a blood spill, immediately clean the area with a cloth soaked with a tuberculocidal 

disinfectant or a 1:100 dilution of household bleach (300-600 mg/L free chlorine) (i.e., 

intermediate-level disinfection). The staff member doing the cleaning shall wear gloves, 

and the cloth shall be placed in a bucket or other leak proof container. 


Published methods shall be used to clean and disinfect the water treatment and distribution 

system and the internal circuits of the dialysis machine, as well as to reprocess dialysers 

for reuse. 

These methods are designed to control bacterial contamination, but will also eliminate 

blood-borne viruses. For single-pass machines, perform rinsing and disinfection 

procedures at the beginning or end of the day. 

For batch re-circulation machines, drain, rinse, and disinfect after each use. Follow the 

same methods for cleaning and disinfection if a blood leak has occurred, regardless of the 

type of dialysis machine used. 

 

the recommendations. 

Venous pressure transducer protectors shall be used to cover pressure monitors and shall 

be changed between patients, not reused. If the external transducer protector becomes 

 

 

after the treatment is completed and check for contamination. This includes inspection for 

possible blood contamination of the internal pressure tubing set and pressure sensing port. 

If contamination has occurred, the machine must be taken out of service and disinfected 

using either 1:100 dilution of bleach (300--600 mg/L free chlorine) or a commercially 

available, EPA-registered tuberculocidal germicide before reuse. 

Housekeeping staff members in the dialysis facility shall promptly remove soil and 

potentially infectious waste and maintain an environment that enhances patient care. 

All disposable items shall be placed in bags thick enough to prevent leakage. Wastes 

generated by the haemodialysis facility might be contaminated with blood and shall be 

considered infectious and handled accordingly. 

50 


Appendix 13 

Recommended training on Infection Control in dialysis 

(Adapted from CDC guidelines) 

Staff Training 

Training and education for all employees at risk for occupational exposure to blood shall be 

provided at least annually, given to new employees before they begin working in the unit, and 

documented. At a minimum, they shall include information on the following topics: 

 

 

 

 

 

 

 

 

 

 

Proper hand hygiene technique; 

Proper use of protective equipment; 

Modes of transmission for blood borne viruses, pathogenic bacteria, and other 

microorganisms as appropriate; 

Infection control practices recommended for haemodialysis units and how they differ from 

Standard Precautions recommended for other health-care settings; 

Proper handling and delivery of patient medications; 

Rationale for segregating HBs Ag positive patients with a separate room, machine, 

instruments, supplies, medications, and staff members; 

Proper infection control techniques for initiation, care, and maintenance of access sites; 

Housekeeping to minimize transmission of microorganisms, including proper methods to 

clean and disinfect equipment and environmental surfaces; and 

Centralized record keeping to monitor and prevent complications, including routine 

serologic testing results for HBV and HCV, hepatitis B vaccine status, episodes of 

bacteraemia and loss of access caused by infection, and other adverse events. 

Records of surveillance for water and dialysate quality shall also be maintained. 


Patient and Family Member Training 

Training and education of patients (or family members for patients unable to be responsible for 

their own care) regarding infection control practices shall be given on admission to dialysis and 

at least annually thereafter and shall address the following topics: 

 

 

 

Personal hygiene and hand washing technique; 

Patient responsibility for proper care of the access and recognition of signs of infection, 

which shall be reviewed each time the patient has a change in access type; and 

Recommended vaccinations 

52 


References 

1 

haemodialysis and related therapies. International Organization for Standardization 

2 Centers for Disease Control and Prevention. Recommendations for preventing 

transmission of infections among chronic haemodialysis patients. MMWR 2001; 50 (No 

RR-5): 1-43 

3 Centers for Disease Control and Prevention: Infection Control Requirements for Dialysis 

- MMWR 

August 15, 2008 / 57(32); 875-876 


GLOSSARY 

AAMI 

ABS 

ALT 

ANSI 

CFU 

EBCT 

ELISA 

ESA 

EU 

FPS 

GMP 

Hb 

HbA1C 

HBs Ab 

HBs Ag 

HCV 

HD 

HDF 

HDPE 

HIV 

IDWG 

iPTH 

ISO 

LAL 

NAT 

PEX 

PIC 

PPM 

RIBA 

RO 

SOP 

TCV 

TGEA 

TIBC 

UF 

Association for the Advancement of Medical Instrumentation 

Acrylonitrile butadiene styrene 

Alanine Transferase 

American National Standards Institute 

Colony Forming Units 

Empty Bed Contact Time 

Enzyme-linked immunosorbent assay 

Erythropoiesis Stimulating Agents 

Endotoxin unit 

Feet per second 

Good Manufacturing Practice 

Haemoglobin 

Haemoglobin A1C 

Hepatitis B surface Antibody 

Hepatitis B surface Antigen 

Hepatitis C Virus 

Haemodialysis 

 

High Density Polyethylene 

 

Interdialytic Weight Gain 

Intact Parathyroid hormone 

International Organization for Standardization 

Limulus Amoebocyte Lysate 

Nucleic Acid Test 

Cross linked Polyethylene 

Person In Charge 

Planned Preventive Maintenance 

Recombinant immunoblot assay 

Reverse Osmosis 

Standard Operating Procedure 

Total cell volume 

Trypton Glucose Extract Agar 

Total Iron Binding Capacity 

 

54 


UKM 

URR 

Urea Kinetic Modelling 

Urea Reduction Ratio 

For the purpose of this standard, the auxiliary verb: 

 

 

 

“shall” means that compliance with a requirement or a test is mandatory for compliance with 

this standard; 

“should” means that compliance with a requirement or a test is recommended but is not 

mandatory for compliance with this standard; 

“may” is used to describe a permissible way to achieve compliance with a requirement or 

test. 


MINISTRY OF HEALTH MALAYSIA 

MEDICAL DEVELOPMENT DIVISION 

Block E1, Parcel E, Federal Government Administrative Centre, 

62590 Putrajaya, Malaysia. 

Tel : 603-8883 1047 Fax : 603-8883 1427 

http://www.moh.gov.my

haemodialysis_quality_standards - Rotary International District 3310

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